OncoMatch/Clinical Trials/NCT05660083
Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)
Is NCT05660083 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies L-NMMA for her2-negative breast cancer.
Treatment: L-NMMA — This is a research study to test the safety and effectiveness of using the drug alpelisib together with chemotherapy (nab-paclitaxel) and a drug called L-NMMA in patients with HER2 negative metastatic or locally advanced metaplastic breast cancer, who have not responded to previous treatments. Participants in this study in addition to the standard care chemotherapy will also receive the drug alpelisib and L-NMMA. The therapies will be administered every 3 weeks (1 cycle) until disease progression, toxicity or until the participant withdraws from the study. The nab-paclitaxel chemotherapy will be administered intravenously on Day 1 of the 3 week cycles. Participants will take the drug alpelisib by mouth once daily at a dose determined by a safety study and the drug L-NMMA will be given intravenously on days 1 to 5 of the 3 week cycles.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: HER2 (ERBB2) negative
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: nab-paclitaxel (nab-paclitaxel)
Received previous treatment with nab-paclitaxel
Cannot have received: PI3K inhibitor
Received previous treatment with Pl3K inhibitor
Cannot have received: AKT inhibitor
Received previous treatment with AKT inhibitor
Cannot have received: mTOR inhibitor
Received previous treatment with mTOR inhibitor
Lab requirements
Blood counts
Hemoglobin ≥9.0 g/dl (without blood transfusion within 2 weeks of laboratory test used to determine eligibility); Absolute neutrophil count ≥1000/μL (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility); Platelet count ≥100,000/μL (without transfusion within 2 weeks of laboratory test used to determine eligibility)
Kidney function
Creatinine ≤1.5X the ULN or measured creatinine clearance ≥ 60 mL/min/1.
Liver function
Serum total bilirubin (TB) ≤1.5 x institutional upper limit of normal (ULN; In the case of known Gilbert's syndrome, a higher serum TB [>1.5 x ULN] is allowed), Aspartate transaminase/alanine transaminase ≤5 x institutional ULN
Cardiac function
No symptomatic congestive heart failure, history of documented congestive heart failure (NYHA III-IV), documented cardiomyopathy, left ventricular ejection fraction <50%, myocardial infarction ~6 months prior to enrollment, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, symptomatic pericarditis, history of congenital QT prolongation, or absolute corrected QT interval of >480 msec in the presence of potassium >4.0 mEq/L and magnesium >1.8 mg/dl.
Adequate organ and marrow function as defined below: Hemoglobin ≥9.0 g/dl... Platelet count ≥100,000/μL... Serum total bilirubin (TB) ≤1.5 x institutional upper limit of normal (ULN; In the case of known Gilbert's syndrome, a higher serum TB [>1.5 x ULN] is allowed), Aspartate transaminase/alanine transaminase ≤5 x institutional ULN, Creatinine ≤1.5X the ULN or measured creatinine clearance ≥ 60 mL/min/1.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institute of Health Clinical Center · Bethesda, Maryland
- Houston Methodist Neal Cancer Center · Houston, Texas
- The University of Texas MD Anderson Cancer Center · Houston, Texas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify